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Reservoir Bag

by Marquette Medical, Inc.

510(k) K873494

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873494 Date30 Dec 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RESERVOIR BAG is a single-use medical device designed to collect, store, and transport fluids in a general hospital setting. It functions as a containment system for biological or therapeutic liquids, ensuring safe handling and disposal after use. The device is constructed to maintain integrity during transport and storage, supporting clinical workflows that require temporary fluid management.

This device is supplied by Marquette Medical, Inc. and is intended for single-use only, with no reprocessing or reuse permitted. It is classified as a Class 2 general hospital device under product code FRN and is regulated under 21 CFR 880.5725. The device is not MRI-conditional and should be stored in a dry, cool environment prior to use. Its regulatory status is documented under FDA 510(k) clearance K873494, with a substantial equivalence determination.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RESERVOIR BAG used for?

    It is a single-use device for collecting, storing, and transporting biological or therapeutic fluids in general hospital settings. It supports temporary fluid management while maintaining integrity during transport and storage.

  • How is the RESERVOIR BAG supplied?

    It is supplied by Marquette Medical, Inc. and is intended for single-use only. No reprocessing or reuse is permitted, and it should be stored in a dry, cool environment prior to use.

  • Is the RESERVOIR BAG sterile?

    The device data does not specify a sterility claim. It is classified as a Class 2 general hospital device under product code FRN and regulated under 21 CFR 880.5725, but no explicit sterile packaging details are provided in the available information.

  • What sizes or models are available?

    The device data does not list specific sizes or model variants. The RESERVOIR BAG is identified by its product name and regulatory clearance number K873494, with no additional dimensional or capacity specifications included.

  • What is the regulatory status of the RESERVOIR BAG?

    The device is documented under FDA 510(k) clearance K873494, with a substantial equivalence determination. It is classified as a Class 2 general hospital device under product code FRN and regulated under 21 CFR 880.5725.